Simplifying First Trimester Medical Abortion Follow-up | NCT03014193

Studies
Simplifying First Trimester Medical Abortion Follow-up

NCT03014193

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Nov 6, 2017Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Medical Abortion

Interventions

Semiquantitative Multi-Level Pregnancy Test

Countries

Armenia
Georgia
Kazakhstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jan 5, 2017

First Submission Date that Met QC Criteria

Jan 5, 2017

First Posted Date

Jan 9, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2017

Last Update Posted Date

Nov 6, 2017Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Name	Type	Description	Arm Group Labels	Other Names
Semiquantitative Multi-Level Pregnancy Test	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Understanding of the instructions for the multilevel pregnancy test		14 days
Ability to independently use the multilevel pregnancy tests		14 days
Ability to interpret the results of the multilevel pregnancy test		14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a first trimester pregnancy with a gestational age of ≤63 days;
Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol;
Be able to read and understand the local language or Russian;
Have access to a telephone;
Agree to follow all study procedures;
Have no contraindication to participation in the study, in the judgment of the site investigator or designee.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women seeking medical abortion with pregnancies of 63 days or less.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gyumri Maternity Hospital		Gyumri			Armenia
Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology